Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

Официальное название

Minimally Invasive Bleb-Forming Surgical Approaches for Treating Primary Open-Angle Glaucoma: A Randomized Controlled Trial Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

Обзор

The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery.  The main questions it aims to answer are: * Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to the XEN®-63 Gel Stent? * How do the two devices compare over 24 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures? Participants will: * Be randomly assigned (1:1) to receive either the XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery. * Attend scheduled follow-up visits over 24 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments. * Receive standard postoperative care and report any complications or additional treatments during the study period.

Вмешательства

• Устройство XEN®-63 Gel Stent
  The XEN®-63 Gel Stent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.
• Устройство PRESERFLO™ MicroShunt
  The PRESERFLO™ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.

Первичные конечные точки

• Intraocular pressure [Срок оценки: 1 year]

Вторичные конечные точки (7)

• Number of medications [Срок оценки: 2 year]
• adverse events [Срок оценки: 2 years]
• secundary pressure-lowering surgery [Срок оценки: 2 years]
• Mean Deviation changes on the visual field [Срок оценки: 2 years]
• Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography [Срок оценки: 2 years]
• Endothelial Cell Count [Срок оценки: 2 years]
• Best Corrected Visual Acuity [Срок оценки: 2 years]

Критерии участия

Критерии включения

• >40 years of age
• An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX)
• Inadequately controlled on maximum tolerated medical therapy.
• Mean Deviation (MD) </= -3
• Intraocular pressure of 14-28 mmHg
• Endothelial Cell Count ≥1000 cells/mm2

Критерии исключения

• An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX)
• Lens status: Aphakic patients or Anterior chamber intraocular lens
• Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months.
• Presence of intraocular silicone oil
• No light perception vision
• Current corticosteroid use (ocular or oral)
• Conjunctival pathologies (e.g., pterygium)
• Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
• Vitreous present in the anterior chamber
• Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
• Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• University Hospitals UZ Leuven — Leuven

Германия · 1 центр

• Universitätsklinikum Bonn — Bonn

Португалия · 1 центр

• ULS Santa Maria — Lisbon

Идентификаторы

NCT: NCT07359547 · S70640

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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